Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria

Lupus Nephritis Clinical Trial

Official title:

Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935389
• Other study ID #: NJCT-0903
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: August 1, 2011
• Start date: April 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2009
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.

Description:

Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.

2. Urine protein=3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.

3. All cases are type IV, confirmed by renal biopsy.

4. All patients sign the informed consent and be willing to follow-up on time

Exclusion Criteria:

1. Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.

2. Scr level above 1.5mg/dL, lasts more than 3 months.

3. Heart, lung or central nervous systems involved or combined with severe infection.

4. With liver function abnormal, ALT or AST being two times above the normal.

5. Pregnant women or patients still in lactation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CTX
• Lupus Nephritis
• Proteinuria

Intervention

Drug:
• tripterygium glycosides
The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital	Nanjing	Jiangsu
China	Research Institute of Nephrology,Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.		48 months	Yes